FDA Issues Warning About Fraudulent Flu Products

Federal health officials in the US have issued a consumer warning about fraudulent products making unsubstantiated claims that they can treat, cure, or prevent the flu virus.

“As the flu continues to make people sick — and even cause deaths — scammers are alive and well, promoting their fraudulent products to the unsuspecting public,” the Food and Drug Administration (FDA) said Friday in a statement.

“These scammers sell their products with claims to prevent, treat or cure the flu, even though they have not been tested and the Food and Drug Administration (FDA) has not approved them,” they added. “FDA warns consumers to steer clear of fraudulent flu products, which can be found online and in retail stores and may include products marketed as dietary supplements or conventional foods, drugs, nasal sprays and devices.”

Specifically, the agency is warning customers to look for specific claims on a product, which could be a red flag that the supposed treatment had not been tested or approved by the FDA.

Those claims, according to UPI reports, include reducing the length and severity of flu symptoms, boosting immunity naturally or without a flu shot, or supporting the body´s natural immune defenses to fight off the influenza virus. Additionally, they advise consumers to be wary of products claiming to be alternatives to the flu vaccine.

“These unproven products give consumers a false sense of security,” added Mary Malarkey, director of FDA’s Office of Compliance and Biologics Quality. “There is no need to buy a product that claims to be an alternative to the vaccine. Flu vaccine is still available and it’s not too late to get vaccinated.”

There are two FDA-approved antiviral drugs which have been recommended by the Centers for Disease Control and Prevention (CDC) as treatment options for those suffering from the flu, the agency said. Those drugs, Tamiflu (oseltamivir) and Relenza (zanamivir), can help prevent contracting the illness, can combat the virus in a person´s body, and can also shorten the amount of time that a person spends fighting the flu.

“There are no legally marketed over-the-counter (OTC) drugs to prevent or cure the flu. However, there are legal OTC products to reduce fever and to relieve muscle aches, congestion, and other symptoms typically associated with the flu,” the FDA said.

“But unapproved drugs (which sometimes are marketed as dietary supplements), conventional foods (such as herbal teas) or devices (such as air filters and light therapies) are fraudulent if they make flu prevention, treatment or cure claims” because those claims have not been evaluated by the agency, they added.

As part of their crackdown on the companies marketing these types of products, last week the FDA issued a warning letter to one firm marketing a nasal spray that they claim has been “laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses,” USA Today´s Elizabeth Weise reported on Wednesday.

The recipient of that letter, Florida-based Flu & Cold Defense LLC, manufactures the over-the-counter product, GermBullet, which they say is made from “pure essential oils,” Weise said. Their claim that it can help battle cold and flu symptoms is a “false and misleading promotional statement,” the FDA said, making the company guilty of illegally marketing a misbranded drug, according to the newspaper report.

“GermBullet is being sold as a drug that claims to treat or cure a disease, but the company has never presented it to the FDA to be vetted as a drug“¦ [and] GermBullet’s website claims it has been tested by an FDA-recognized virology lab, but no FDA-recognized lab has seen it,” Weise said. “The company has 15 days to answer the warning letter. If the company continues to make unsubstantiated claims about the product, the agency may take enforcement action that could include seizure of the drug or criminal prosecution.”